16 05, 2018

Ready to Make Your Job a Whole Lot Easier?

By | 2018-05-17T11:13:58+00:00 May 16th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, FDA Warning Letters, FDAzilla, Food, Form FDA 483, Medical Devices|

We continuously monitor, collect, sort, tag, and link data from multiple agencies to enable bespoke reports, user-friendly searches, and automated alerts. Equipped with this unrivaled information, you’ll reduce regulatory risk, maximize actionable insights, and minimize research time.

7 05, 2018

114 New FDA 483s | May 7th 2018

By | 2018-05-07T13:46:02+00:00 May 7th, 2018|Biopharma / Pharma, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

3 05, 2018

The Secret Life of (b)s

By | 2018-05-03T16:09:42+00:00 May 3rd, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Food, Form FDA 483, Medical Devices|

I recently discovered a gap in my education. Like you, I’ve seen my share of redacted 483s and EIRs. Those redactions are marked with a “(b)” followed by a number in parentheses. I’m normally a curious person, but it never occurred to me that those letters and numbers had a meaning. I had an aha (and color me red) moment [...]

23 04, 2018

66 New FDA 483s | April 23rd 2018

By | 2018-04-23T15:35:34+00:00 April 23rd, 2018|Biopharma / Pharma, FDA Enforcement Trends, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

19 04, 2018

A Look Into the Foreign Food Facility Inspection Program

By | 2018-04-19T15:36:57+00:00 April 19th, 2018|cGMP Quality Assurance and FDA 483s, FDAzilla, Food, FSMA|

Due to a recent push by the FDA for more foreign food inspections, it is important that all foreign facilities are up to par. No matter what capacity they contribute in (packing, processing, or holding food) these facilities are subject to inspection by the FDA. It can be difficult to navigate new requirements for foreign facilities under FSMA, but [...]

12 04, 2018

93 New FDA 483s | April 12th 2018

By | 2018-04-12T16:03:53+00:00 April 12th, 2018|Biopharma / Pharma, FDAzilla, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

11 04, 2018

3 Strategies to Monitor 1,000+ Suppliers

By | 2018-04-11T14:14:50+00:00 April 11th, 2018|Food, FSMA, Supplier Management|

There is no denying the complexities of FSMA and the demands it places on large companies in the food industry. In-depth record-keeping accompanying extensive preventative control measures are a headache for food processors - at best. The real complications enter, however, when the responsibility of large companies increases exponentially with the requirement of an FSVP. It is difficult to [...]

3 04, 2018

The 8 Best Articles for FSMA Preparation

By | 2018-04-03T12:36:11+00:00 April 3rd, 2018|cGMP Quality Assurance and FDA 483s, Food, FSMA|

FSMA compliance takes a lot of work and determining exactly what food processors, growers, importers, or others in the industry should be doing is something that experts have been writing about. Some articles are purely informational while others provide definitive steps forward. We’ve compiled 8 of the best below: 1. FSMA in a Nutshell In the whirlwind of details [...]

2 04, 2018

Deep Dive into FSMA Foreign Supplier Verification: 5 Pitfalls to Avoid

By | 2018-04-02T16:54:09+00:00 April 2nd, 2018|cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, Food, FSMA|

FSMA (which was signed into law in 2011) laid out many new demands for food processors in the United States. One aspect of FSMA was shifting the responsibility of food safety onto importers by requiring a Foreign Supplier Verification Program (FSVP) to monitor all foreign suppliers. With this complex system in place, it is important to avoid the pitfalls [...]